The first oral treatment for MS

By: Maureen McFadden Email
By: Maureen McFadden Email

For the first time ever, MS patients have a way to treat their disease with no needles.

Multiple Sclerosis is a disease that affects about 400,000 Americans. The body's immune system turns on itself and attacks the brain. It is a disease that slowly robs patients of their ability to walk, see and even think clearly. Until now, patients had to rely on injections for help.

Now, the very first oral medication for MS has patients talking.

The FDA has approved the first oral treatment called Gilenya (juh-lee-knee-uh).

Dr. Jeffrey Dunn, clinical neuro-immunologist at Stanford school of medicine, says, "Patients are excited about that because it is an oral product. We have never had that before."

The body's immune system attacks Myelin (my-lin), a substance that protects nerves. Gilenya works by holding certain immune cells in the lymph nodes so they can't reach the myelin.

In clinical studies, Gilenya reduced ms relapses by 54 percent compared to a placebo and by 52 percent compared to another common injectable drug. But some say doctors should be cautious when prescribing the oral medication.

Dr. Melissa Ortega, clinical instructor/ms specialist at the University of Miami says, "What we don't know is what can happen long-term, and we don't know that until we have a lot more patients on the drug."

Gilenya can also cause serious side effects like slowed heart rate, liver problems, headaches and a build-up of fluid in the eye.

Dr. Dunn explains that currently, there are four other oral medications in the final phase of clinical trial testing that could become FDA approved soon.

An interesting fact is that the closer you live to the equator, the less at risk you are for the disease. Your chances greatly increase the further away you live.

Research summary:

Background: according to the national institute of neurological disorders and stroke, no one knows exactly how many people have multiple sclerosis. However, it is believed that there are approximately 250,000 to 350,000 sufferers in the United States. Most people experience their first symptoms of ms between the ages of 20 and 40, but a diagnosis is often delayed. There are four types of ms. Relapsing-remitting ms (rrms) is the most common form. About 75 percent to 85 percent of people with ms are initially diagnosed with rrms. Secondary-progressive ms (spms) is another type of ms. With spms, symptoms worsen more steadily over time, with or without the occurrence of relapses and remissions. Primary-progressive ms (ppms) occurs in about 10 percent of people with ms. It is characterized by slowly worsening symptoms from the beginning, with no relapses or remissions. Finally, there is progressive-relapsing ms (prms). This type affects about 5 percent of ms patients. Prms is characterized by a steadily worsening disease state from the beginning, with acute relapses but no remissions. (source: national institute of neurological disorders and stroke)

Treatment: currently, there is no cure for ms. Many patients do well with no therapy at all, especially since many medications have serious side effects and carry significant risks. There are various ms treatment options available. Some have shown to decrease the frequency of relapses and delay disease progression. Some treatments use an injection or are taken intravenously, while others, like the newly FDA-approved gilenya, are taken orally.

New oral option: gilenya is a first-line treatment for relapsing forms of ms. It is the first oral disease-modifying therapy available for the long-term treatment of ms. Gilenya is a new option for people who are uncomfortable with injections or experience side effects from injections.

How gilenya works in ms is unknown, but it is thought that the drug keeps more lymphocytes inside the lymph nodes, so that fewer can be released to attack nerve fibers in the brain, spinal cord, and the eyes. The pill does have serious side effects, with possible heart, lung, and eye toxicity and increased risk of infection. Patients must be closely monitored, and regular eye exams are advised. Overall, the drug's benefits outweighed its risks among the more than 2,600 ms patients who took the it in clinical trials. (source: webmd, www.gilenya.com)


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